Long-term omeprazole treatment in resistant gastroesophageal reflux disease: Efficacy, safety, and influence on gastric mucosa

Background & Aims: The efficacy and safety of long-term acid suppression re mains a subject for debate. We report data from patients with refractory re flux esophagitis who were undergoing maintenance therapy with greater than or equal to 20 mg omeprazole daily for a mean period of 6.5 years (range, 1 .4-11.2 years). Methods: Patients with severe reflux esophagitis resistant to long-term therapy with H-2-receptor antagonists and who were not eligibl e for surgery were evaluated at least annually for endoscopic relapse and h istological changes in the gastric corpus. Results: In 230 patients (mean a ge, 63 years at entry; 36% were greater than or equal to 70 years), there w ere 158 relapses of esophagitis during 1490 treatment years (1 per 9.4 year s), with no significant difference in relapse rates between Helicobacter py lori-positive and -negative patients. Ail patients reheated during continue d therapy with omeprazole at the same or higher dose. The annual incidence of gastric corpus mucosal atrophy was 4.7% and 0.7% in H, pylori-positive a nd -negative patients, respectively, which was mainly observed in elderly p atients who had moderate/severe gastritis at entry. In patients with baseli ne moderate/severe gastritis, the incidences were similar: 7.9% and 8.4%, r espectively. Corpus intestinal metaplasia was rare, and no dysplasia or neo plasms were observed. The adverse event profile was as might be expected fr om this elderly group of patients. Conclusions: Long-term omeprazole therap y (up to 11 years) is highly effective and safe for control of reflux esoph agitis.